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Your search keyword '"Cramer, Sarah D."' showing total 20 results
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20 results on '"Cramer, Sarah D."'

3. Agreement in Histological Assessment of Mitotic Activity Between Microscopy and Digital Whole Slide Images Informs Conversion for Clinical Diagnosis

Author

Wei, Bih-Rong, Halsey, Charles H., Hoover, Shelley B., Puri, Munish, Yang, Howard H., Gallas, Brandon D., Lee, Maxwell P., Chen, Weijie, Durham, Amy C., Dwyer, Jennifer E., Sánchez, Melissa D., Traslavina, Ryan P., Frank, Chad, Bradley, Charles, McGill, Lawrence D., Esplin, D. Glen, Schaffer, Paula A., Cramer, Sarah D., Lyle, L. Tiffany, Beck, Jessica, Buza, Elizabeth, Gong, Qi, Hewitt, Stephen M., and Simpson, R. Mark

Published
2019
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4. Toxicologic Neuropathology of Novel Biotherapeutics

Author

Bangari, Dinesh S., primary, Lanigan, Lisa G., additional, Cramer, Sarah D., additional, Grieves, Jessica L., additional, Meisner, René, additional, Rogers, Arlin B., additional, Galbreath, Elizabeth J., additional, and Bolon, Brad, additional

Published
2023
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11. Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing.

Author

Bennet, Bindu M., Pardo, Ingrid D., Assaf, Basel T., Buza, Elizabeth, Cramer, Sarah D., Crawford, LaTasha K., Engelhardt, Jeffery A., Galbreath, Elizabeth J., Grubor, Branka, Morrison, James P., Osborne, Tanasa S., Sharma, Alok K., and Bolon, Brad

Subjects
GANGLIA, ANIMAL species, AUTONOMIC ganglia, SENSORY ganglia, CENTRAL nervous system, SPINAL nerve roots
Abstract

Dorsal root ganglia (DRG), trigeminal ganglia (TG), other sensory ganglia, and autonomic ganglia may be injured by some test article classes, including anti-neoplastic chemotherapeutics, adeno-associated virus-based gene therapies, antisense oligonucleotides, nerve growth factor inhibitors, and aminoglycoside antibiotics. This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findings related to TA administration may result from TA exposure and/or trauma related to direct TA delivery into the central nervous system or ganglia. In some cases, TA-related effects may need to be differentiated from a spectrum of artifactual and/or spontaneous background changes. [ABSTRACT FROM AUTHOR]

Published
2023
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12. Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies

Author

O’Brien, Maureen T., primary, Schuh, JoAnn C. L., additional, Wancket, Lyn M., additional, Cramer, Sarah D., additional, Funk, Kathleen A., additional, Jackson, Nicolette D., additional, Kannan, Kamala, additional, Keane, Kevin, additional, Nyska, Abraham, additional, Rousselle, Serge D., additional, Schucker, Adrienne, additional, Thomas, Valerie S., additional, and Tunev, Stefan, additional

Published
2022
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13. sj-docx-1-tpx-10.1177_01926233221103202 – Supplemental material for Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies

Author

O’Brien, Maureen T., Schuh, JoAnn C. L., Wancket, Lyn M., Cramer, Sarah D., Funk, Kathleen A., Jackson, Nicolette D., Kannan, Kamala, Keane, Kevin, Nyska, Abraham, Rousselle, Serge D., Schucker, Adrienne, Thomas, Valerie S., and Tunev, Stefan

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental material, sj-docx-1-tpx-10.1177_01926233221103202 for Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies by Maureen T. O’Brien, JoAnn C. L. Schuh, Lyn M. Wancket, Sarah D. Cramer, Kathleen A. Funk, Nicolette D. Jackson, Kamala Kannan, Kevin Keane, Abraham Nyska, Serge D. Rousselle, Adrienne Schucker, Valerie S. Thomas and Stefan Tunev in Toxicologic Pathology

Published
2022
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15. Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies.

Author

O'Brien, Maureen T., Schuh, JoAnn C. L., Wancket, Lyn M., Cramer, Sarah D., Funk, Kathleen A., Jackson, Nicolette D., Kannan, Kamala, Keane, Kevin, Nyska, Abraham, Rousselle, Serge D., Schucker, Adrienne, Thomas, Valerie S., and Tunev, Stefan

Subjects
MEDICAL equipment, ARTIFICIAL implants, INTERNATIONAL organization, GOVERNMENT agencies, EMPLOYEE reviews, BEST practices, EVALUATION methodology
Abstract

Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and microscopic pathology evaluations due to the physical presence of the device itself and unique tissue responses to device materials. The Medical Device Implant Site Evaluation working group of the Society of Toxicologic Pathology's (STP) Scientific and Regulatory Policy Committee (SRPC) was tasked with reviewing scientific, technical, and regulatory considerations for these studies. Implant site evaluations require highly specialized methods and analytical schemes that should be designed on a case-by-case basis to address specific study objectives. Existing STP best practice recommendations can serve as a framework when performing nonclinical studies under Good Laboratory Practices and help mitigate limitations in standards and guidances for implant evaluations (e.g., those from the International Organization for Standardization [ISO], ASTM International). This article integrates standards referenced by sponsors and regulatory bodies with practical pathology evaluation methods for implantable medical devices and combination products. The goal is to ensure the maximum accuracy and scientific relevance of pathology data acquired during a medical device or combination drug-device implantation study. [ABSTRACT FROM AUTHOR]

Published
2022
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16. Proliferative and Nonproliferative Lesions of the Rat and Mouse Central and Peripheral Nervous Systems: New and Revised INHAND Terms

Author

Bradley, Alys E., primary, Bolon, Brad, additional, Butt, Mark T., additional, Cramer, Sarah D., additional, Czasch, Stephanie, additional, Garman, Robert H., additional, George, Catherine, additional, Gröters, Sibylle, additional, Kaufmann, Wolfgang, additional, Kovi, Ramesh C., additional, Krinke, Georg, additional, Little, Peter B., additional, Narama, Isao, additional, Rao, Deepa B., additional, Sharma, Alok K., additional, Shibutani, Makoto, additional, and Sills, Robert, additional

Published
2020
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17. Supplemental_material - Agreement in Histological Assessment of Mitotic Activity Between Microscopy and Digital Whole Slide Images Informs Conversion for Clinical Diagnosis

Author

Bih-Rong Wei, Halsey, Charles H., Hoover, Shelley B., Munish Puri, Yang, Howard H., Gallas, Brandon D., Lee, Maxwell P., Weijie Chen, Durham, Amy C., Dwyer, Jennifer E., Sánchez, Melissa D., Traslavina, Ryan P., Frank, Chad, Bradley, Charles, McGill, Lawrence D., D. Glen Esplin, Schaffer, Paula A., Cramer, Sarah D., L. Tiffany Lyle, Beck, Jessica, Buza, Elizabeth, Gong, Qi, Hewitt, Stephen M., and R. Mark Simpson

Subjects
Medicine
Abstract

Supplemental_material for Agreement in Histological Assessment of Mitotic Activity Between Microscopy and Digital Whole Slide Images Informs Conversion for Clinical Diagnosis by Bih-Rong Wei, Charles H. Halsey, Shelley B. Hoover, Munish Puri, Howard H. Yang, Brandon D. Gallas, Maxwell P. Lee, Weijie Chen, Amy C. Durham, Jennifer E. Dwyer, Melissa D. Sánchez, Ryan P. Traslavina, Chad Frank, Charles Bradley, Lawrence D. McGill, D. Glen Esplin, Paula A. Schaffer, Sarah D. Cramer, L. Tiffany Lyle, Jessica Beck, Elizabeth Buza, Qi Gong, Stephen M. Hewitt and R. Mark Simpson in Academic Pathology

Published
2019
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18. Automated Computational Detection, Quantitation, and Mapping of Mitosis in Whole-Slide Images for Clinically Actionable Surgical Pathology Decision Support

Author

Puri, Munish, primary, Hoover, Shelley B., additional, Hewitt, Stephen M., additional, Wei, Bih-Rong, additional, Adissu, Hibret Amare, additional, Halsey, Charles H.C., additional, Beck, Jessica, additional, Bradley, Charles, additional, Cramer, Sarah D., additional, Durham, Amy C., additional, Esplin, D. Glen, additional, Frank, Chad, additional, Lyle, L. Tiffany, additional, McGill, Lawrence D., additional, Sánchez, Melissa D., additional, Schaffer, Paula A., additional, Traslavina, Ryan P., additional, Buza, Elizabeth, additional, Yang, Howard H., additional, Lee, Maxwell P., additional, Dwyer, Jennifer E., additional, and Simpson, R. Mark, additional

Published
2019
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